Key facts
| Recalling firm | Boston Scientific Neuromodulation Corporation |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 |
| Classification | Class II |
| Recall number | Z-2404-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | Sterile anchors my lack sterility assurance. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Boston Scientific Neuromodulation Corporation and the affected product is described in FDA's record as: Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180. FDA's stated reason for the recall is: Sterile anchors my lack sterility assurance.. The recall is tracked under FDA recall number Z-2404-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 -- and the recall number Z-2404-2026. If it matches, stop using or distributing it and contact Boston Scientific Neuromodulation Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Boston Scientific Neuromodulation Corporation’s FDA history
Argus HQ has recorded 3 total FDA actions tied to Boston Scientific Neuromodulation Corporation: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Has Boston Scientific Neuromodulation Corporation had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 3 total FDA actions tied to Boston Scientific Neuromodulation Corporation, including 3 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2404-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
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Related enforcement actions
Full FDA history for Boston Scientific Neuromodulation CorporationCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: Boston Scientific Model SC-4318, Clik X Anchor REF:… by Boston Scientific Neuromodulation Corporation. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-boston-scientific-neuromodulation-corporation-z-2404-2026
"FDA Recall Database: Class II Recall: Boston Scientific Model SC-4318, Clik X Anchor REF:… by Boston Scientific Neuromodulation Corporation." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-boston-scientific-neuromodulation-corporation-z-2404-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: Boston Scientific Model SC-4318, Clik X Anchor REF:… by Boston Scientific Neuromodulation Corporation." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-boston-scientific-neuromodulation-corporation-z-2404-2026.
@misc{argushq_argushq_ai_recall_fda_recall_boston_scientific_neuromodulation_corporation_z_2404_2026_2026,
title = {FDA Recall Database: Class II Recall: Boston Scientific Model SC-4318, Clik X Anchor REF:… by Boston Scientific Neuromodulation Corporation},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-boston-scientific-neuromodulation-corporation-z-2404-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗